Alpha Medical Llc

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D, Individual Laboratory Profile and review of American Proficiency Institute (API) proficiency testing (PT) reports; the laboratory failed to participate in PT event 3 of 2023 for the routine chemistry analytes, including creatinine and creatine kinase, total (CK, total), and failed to achieve satisfactory performance for creatinine and CK, total in PT event 2 of 2024; resulting in unsuccessful PT performance (event three of 2023 and event two of 2024, see D2096). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D, Individual Laboratory Profile, and review of American Proficiency Institute (API) proficiency testing (PT) documentation; the laboratory failed to successfully participate in PT for the routine chemistry analytes creatinine and creatine kinase, total (CK, total) during event three of 2023 and event two of 2024, resulting in the unsuccessful PT performance for creatinine and CK, total. Findings include: 1. Review of the CASPER Report 0155D, ran on 07-01-2024, identified the initial unsuccessful PT performance in the specialty of chemistry for creatinine and CK, total. ROUTINE CHEMISTRY creatinine - Event 3, 2023 = 0% - Unsatisfactory creatinine - Event 2, 2024 = 40% - Unsatisfactory CK, total - Event 3, 2023 = 0% - Unsatisfactory CK, total - Event 2, 2024 = 0% - Unsatisfactory 2. Review of API PT documentation confirmed the unsuccessful PT performance for creatinine and CK, total during event three of 2023 and event two of 2024. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D, Individual Laboratory Profile, and review of American Proficiency Institute (API) proficiency testing (PT) reports; the laboratory director failed to meet the requirements of this condition. The laboratory director failed to ensure PT samples were tested as required (see D6089). D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D, Individual Laboratory Profile, and review of American Proficiency Institute (API) proficiency testing (PT) reports; the laboratory director failed to successfully participate in PT for the routine chemistry analytes creatinine and creatine kinase, total (CK, total) during event three of 2023 and event two of 2024, resulting in the unsuccessful PT performance for creatinine and CK, total (see D2096). -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D, Individual Laboratory Profile, and review of American Proficiency Institute (API) proficiency testing (PT) reports; the laboratory failed to participate in PT event 3 of 2023 for the routine chemistry analytes, including alkaline phosphatase (ALK PHOS), resulting in unsatisfactory performance (see D2089). In addition, the laboratory failed to achieve successful performance for ALK PHOS in PT event 1 of 2024; resulting in two consecutive event failures (event three of 2023 and event one of 2024, see D2096). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D, Individual Laboratory Profile, and review of American Proficiency Institute (API) proficiency testing (PT) reports; the laboratory failed to participate in event three of 2023 for routine chemistry resulting in unsatisfactory analyte performance for 21 of 21 regulated chemistry analytes. Findings include: 1. Review API PT records for event three of 2023 identified the laboratory failed to participate in PT resulting in a score of 0% for the following regulated analytes: albumin, alkaline phosphatase, alanine transaminase, amylase, aspartate aminotransferase, bilirubin (total), calcium (total), chloride, cholesterol (high density lipoprotein), cholesterol (total), creatine kinase, creatinine, glucose, iron (total), lactate dehydrogenase, magnesium, potassium, sodium, total protein, triglycerides, urea nitrogen, and uric acid. 2. Review of the CASPER Report 0155D confirmed the unsatisfactory scores (0%) for the 21 routine chemistry analytes identified above. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D, Individual Laboratory Profile, and review of American Proficiency Institute (API) proficiency testing (PT) documentation; the laboratory failed to successfully participate in PT for the routine chemistry analyte alkaline phosphatase during event three of 2023 and event one of 2024, resulting in the unsuccessful PT performance for alkaline phosphatase. Findings include: 1. Review of the CASPER Report 0155D, ran on 3-4-2024, identified the initial unsuccessful PT performance in the specialty of chemistry for alkaline phosphatase. ROUTINE CHEMISTRY alkaline phosphatase - Event 3, 2023 = 0% - Unsatisfactory alkaline phosphatase - Event 1, 2024 = 20% - Unsatisfactory 2. Review of API PT documentation confirmed the unsuccessful PT performance for alkaline phosphatase during event three of 2023 and event one of 2024. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 -- 2 of 3 -- The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D, Individual Laboratory Profile, and review of American Proficiency Institute (API) proficiency testing (PT) reports; the laboratory director failed to meet the requirements of this condition. The laboratory director failed to ensure PT samples were tested as required (see D6089). D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D, Individual Laboratory Profile, and review of American Proficiency Institute (API) proficiency testing (PT) reports; the laboratory director (LD) failed to ensure the laboratory participated in event three of 2023 for routine chemistry resulting in unsatisfactory analyte performance for 21 of 21 regulated chemistry analytes (see D2089). The LD also failed to successfully participate in PT for the routine chemistry analyte alkaline phosphatase during event three of 2023 and event one of 2024, resulting in the unsuccessful PT performance for alkaline phosphatase (see D2096). -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the CASPER Report 0155D and American Proficiency Institute (API) proficiency testing (PT) documentation the laboratory failed to successfully participate in PT for the routine chemistry analyte total cholesterol during events one and three of 2023. See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of CASPER Report 0155D and review of American Proficiency Institute (API) proficiency testing (PT) documentation the laboratory failed to successfully participate in PT for the routine chemistry analyte total cholesterol during events one and three of 2023, resulting in the unsuccessful PT performance for total cholesterol. Findings include: 1. Review of the CASPER Report 0155D ran on 11-01- 2023 identified the initial unsuccessful PT performance for the chemistry analyte total cholesterol. ROUTINE CHEMISTRY Cholesterol, total - EVENT-1, 2023 = 40% - Unsatisfactory Cholesterol, total - EVENT-3, 2023 = 0% - Unsatisfactory 2. Review of API PT documentation confirmed the unsuccessful PT performance for total cholesterol during events one and three of 2023. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CASPER Report 0155D and review of American Proficiency Institute (API) proficiency testing (PT) reports the laboratory director failed to meet the requirements of this condition. The laboratory director failed to ensure test methods were performed as required to provide accurate and reliable results for the specialty of chemistry analyte total cholesterol in 2023. See D6087. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of the CASPER Report 0155D and review of American Proficiency Institute (API) proficiency testing (PT) reports the laboratory director failed to ensure test methods were performed as required to provide accurate and reliable results for the specialty of chemistry analyte total cholesterol in 2023. Findings Include: 1. The laboratory failed to ensure successful participation in proficiency testing for the chemistry analyte total cholesterol during events one and three of 2023. See D2096. -- 2 of 2 --

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on surveyor review of the laboratory records, proficiency testing (PT) reports, and interview with the laboratory director (LD); the laboratory failed to properly manage and evaluate the overall quality of testing. The laboratory must meet the requirements in 493.1231 through 493.1236. Findings include: 1. The laboratory failed to verify the accuracy of the Semen Analysis tests it performs in the laboratory. See D5213. 2. The laboratory failed to verify the accuracy bi-annually for semen analysis, microscopic urinalysis, lupus anticoagulants, antiphospholipid antibody ELISA assays, and reproductive immuno phenotype testing performed. See D5217. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on record review, proficiency testing (PT) reports, and an interview with the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 17 -- laboratory director (LD), the laboratory failed to verify the accuracy of the Semen Analysis tests it performs in the laboratory. Findings include: 1. The American Association of Bio analysts (AAB) and American Proficiency Institute (API) PT programs' report, quality control (QC) logs, procedures manual, and patients' final reports were reviewed for the year 2018, 2019, and 2020 for Semen Motility and General Immunology. 2. The PT programs results for Semen Analysis revealed the following: *AAB 2018 Event #2 - Semen Analysis - scored "50%"; *AAB 2019 Event #1 - Sperm Count - score "Not Graded"; *AAB 2019 Event #2 - No documentation provided by LD, no evidence of participation; *API 2020 Event #1 - Sperm Count - scored "100%" 3. The laboratory failed to follow its PT policy to evaluate all PT failures and "no scores". 4. Sperm analysis were performed and reported on 65 patients during the period of 08/25/18 thru 02/25/2020, when the accuracy of it's testing had not been verified. 5. On a Recertification survey 09/02 /2020 at 5:45 PM, the LD confirmed the above findings. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review, proficiency testing (PT) reports, and an interview with the laboratory director (LD), the laboratory failed to verify the accuracy twice annually for semen analysis, microscopic urinalysis, lupus anticoagulants, antiphospholipid antibody ELISA assays, and reproductive immuno phenotype testing performed. Findings include: 1. The American Association of Bio analysts (AAB) and American Proficiency Institute (API) PT, and Medical Laboratory Evaluation (MLE) PT programs' reports, split sample PT reports, quality control (QC) logs, procedures manual, and patients' final reports were reviewed for 2018, 2019, and 2020. Semen Analysis: 2. The final reports of 5 patients selected for review revealed the following results: *Total Count (Sperm) *Total Motility *Prog. (Progressive) Motility *NonProg (Non-Progressive) Motility *Immotile, *Total Motile Count, and *Morphology 3. The AAB and API PT program reports reviewed for 2018, 2019, and 2020 showed the laboratory participated in Total Sperm count and Sperm morphology only. 4. Further review of PT documentation found no bi-annual method to verify accuracy was performed by the laboratory in 2018, 2019 and 2020 for Sperm motility analysis. 5. Sperm motility analysis were performed and reported on 65 patients during the period of 08/25/18 thru 02/25/2020, when the accuracy of it's testing had not been verified. 6. Interview with the LD on 09/02/2020 at 10:30 am confirmed the above findings. Microscopic Urinalysis: 7. Review of MLE PT for 2018, 2019, and 2020 identified the laboratory failed to enroll in microscopic urinalysis PT in 2020. 8. Further review of PT documentation found no bi-annual method accuracy was performed by the laboratory in 2020 for microscopic urinalysis. 9. Interview with the LD on 9-2-2020 at 3:20pm confirmed the laboratory failed to enroll in PT for microscopic urinalysis testing in 2020 with MLE and no alternative arrangements were made to verify the accuracy of this test. 10. Microscopic urinalysis was performed and reported for 148 patients from September of 2019 to August 31, 2020. Lupus Anticoagulant (Lupus Screen): 11. Review of PT documentation found no record of bi-annual method accuracy of lupus anticoagulant testing performed on the ACL 1000 analyzer. 12. Interview with the LD on 9-2-2020 at 3:20pm confirmed the laboratory failed to verify the accuracy of lupus anticoagulant testing in 2018, 2019, -- 2 of 17 -- and 2020. 13. Lupus Screen testing was performed and reported for 25 patients from September of 2019 to August 31, 2020. Antiphospholipid Antibody (APA) ELISA assays: 14. Review of split sample proficiency documentation for APA testing revealed the laboratory failed to perform bi-annual evaluations in 2018 and 2019. 2019 - 1 Review was completed 4-9-2019. 2018 - No reviews documented. 15. APA testing was performed and reported for 216 patients from September of 2019 to August 31, 2020. Reproductive ImmnoPhenotype (RIPh) testing: 16. Review of split sample proficiency documentation for RIPh testing revealed the laboratory failed to perform bi-annual evaluations in 2019. 2019 - 1 Review was completed 5-29-2019. 17. RIPh testing was performed and reported for 338 patients from September of 2019 to August 31, 2020. 18. On a Recertification survey conducted on 09/02/2020 at 5:45 PM, the LD confirmed the above findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on direct observation, record and manual review, manufacturer's instructions, and an interview with the laboratory director (LD), the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283 for performing General Immunology, Semen Analysis, and Hematology testing in the laboratory. Findings Include: 1. The laboratory failed to meet the following analytic systems requirements: *Failed to have written procedures for all assays and tests. D5401. *Failed to ensure all test and assay meet procedures requirements specified in 493.1251(b)(1) - (14). D5403. *Failed to monitor and document manufacturer's required conditions essential for proper storage of test kits. D5413. *Failed to ensure expired supplies are not to be used. See. D5417. *Failed to establish the performance specifications for the laboratory developed tests (LDT) in Flow Cytometry. D5423. *Failed to establish and follow maintenance protocols that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. D5433. *Failed to perform bi-annual calibration procedures. See D5439. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory records and interview with the laboratory director (LD); the laboratory failed to have written procedures for Prothrombin Time (PT), -- 3 of 17 -- activated partial thromboplastin (PTT), and lupus anticoagulant testing performed in the specialty of hematology. Findings Include: 1. The laboratory's coagulation procedure manual was reviewed. 2. Review of the coagulation manual found no written procedures for PT, PTT, and lupus anticoagulant testing performed on the ACL 1000 analyzer. 3. On survey date 9-02-2020, at 6:00 pm, the LD confirmed no individual written procedure were available for each coagulation test performed on the ACL 1000. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and phone communication with the PT vendor American Association of Bioanalysts (AAB); it was confirmed that the laboratory fail to successfully participate in the testing of PT samples under the specialty of Hematology and Diagnostic Immunology. Findings include: 1. Review of PT CASPER Report 155 on May 04, 2020 at 8:0 AM revealed that the unsatisfactory PT performance were Initial and Subsequent PT failures that occurred during the 2019 and 2020 calendar years. See D2084 and D2130. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and phone communication with the PT vendor American Association of Bioanalysts (AAB); it was confirmed that the laboratory fail to successfully participate in the testing of PT samples under the specialty of Diagnostic Immunology. Findings include: 1. Review of PT CASPER Report 155 on May 04, 2020 at 8:00 AM, revealed that the unsatisfactory PT performance was an Initial PT failure that occurred during calendar years 2019 and 2020 as listed below. INITIAL- PT Fail Performance DIAGNOSTIC IMMUNOLOGY Syphilis Serology Event-3, 2019 = 0% Event-1, 2020 = 0% Antinuclearantibody (ANA) Event-3, 2019 = 0% Event-1, 2020 = 0% 2. During PT Desk review on May 04, 2020 and phone communication with the PT vendor AAB at 11:10 AM, the Initial PT failing scores were confirmed. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and phone communication with the PT vendor American Association of Bioanalysts (AAB); it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the specialty of Hematology. Findings include: 1. Review of PT CASPER Report 155 on May 04, 2020 at 8:00 AM, revealed that the unsatisfactory PT performance was a Subsequent and multiple Initial PT failure that occurred during calendar years 2019 and 2020 as listed below. SUBSEQUENT- PT Fail Performance Plateletes Event-2, 2019 = 60% Event-3, 2019 = 0% Event-1, 2020 = 0% INITIAL- PT- Fail Performance Hematology Event-3, 2019 = 0% Event-1, 2020 = 0% Cell ID/White Blood Cell (WBC) Differential Event-3, 2019 = 0% Event- 1, 2020 = 0% Erythrocyte Count Red Bood Cells (RBC) Event-3, 2019 = 0% Event-1, 2020 = 0% Microhematocrit (HCT) Event-3, 2019 = 0% Event-1, 2020 = 0% Hemoglobin (HGB) Event-3, 2019 = 0% Event-1, 2020 = 0% Leucocyte Count (WBC) Event-3, 2019 = 0% Event-1, 2020 = 0% Fibrinogen PTT Event-3, 2019 = 0% Event-1, 2020 = 0% Prothrombin Time (PT) Event-3, 2019 = 0% Event-1, 2020 = 0% 2. During PT Desk review on May 04, 2020 and phone communication with the PT vendor AAB at 11:10 AM, the Subsequent and Initial PT failing scores were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and phone communication with the PT vendor American Association of Bioanalysts (AAB); it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the specialty of Diagnostic Immunology. Findings include: 1. Review of PT CASPER Report 155 on January 06, 2020 at 8:00 AM revealed that the unsatisfactory PT performance occurred during events 2 and 3 of calendar year 2019. See D2084. D2084 GENERAL IMMUNOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- CFR(s): 493.837(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and phone communication with the PT vendor American Association of Bioanalysts (AAB); it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the specialty of Diagnostic Immunology. Findings include: 1. Review of PT CASPER Report 155 on January 06, 2020 at 8:00 AM, revealed that the unsatisfactory PT performance occurred during calendar year 2019 for events 2 and 3 under General Immunology and Cholesterol Total as listed below. DIAGNOSTIC IMMUNOLOGY General Immunology, EVENT-2, 2019 = 50% Unsuccessful General Immunology, EVENT-3, 2019 = 0% Unsuccessful Cholesterol Total, EVENT-2, 2019 = 60% Unsatisfactory Cholesterol Total, EVENT-3, 2019 = 0% Unsatisfactory 2. During PT Desk review on January 06, 2020 and phone communication with the PT vendor AAB on 01/08/2020 at 10:12 AM, the PT failing scores were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and communication with the PT vendor American Association of Bioanalyst (AAB); it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the Specialty of Hematology during calendar year 2019. Findings include: 1. Review of the CASPER Report 155 on December 03, 2019 and communication with the PT vendor AAB at 12:25 PM, the initial unsuccessful PT performance was confirmed under the Specialty of Hematology Platelets. See D-2130. D2130 HEMATOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and communication with the PT vendor American Association of Bioanalyst (AAB); it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the Specialty of Hematology during calendar year 2019. Findings include: 1. Review of the CASPER Report 155 on December 03, 2019 revealed that the initial unsuccessful PT performance occurred under the Specialty of Hematology Platelets during events 2 and 3 of 2019 as listed below: HEMATOLOGY Platelets EVENT -2, 2019 = 60% Unsuccessful Platelets EVENT -3, 2019 = 0% Unsuccessful 2. During a phone communication with the PT vendor AAB on December 03, 2019 at 12:25 PM, confirmed the PT failing scores. -- 2 of 2 --